Charles T. Gombar, Ph.D.
Dr. Gombar received his undergraduate degree in Chemistry from Pace University and his Ph.D. in Pharmacology from the Albany Medical College. The focus of his research was to gain an understanding of the mechanism of action of haloethyl nitrosoureas as antitumor agents at the molecular level. He then did a postdoctoral fellowship at the Fels Research Institute at Temple University where he studied the role of DNA damage and repair in chemical carcinogenesis. In 1982 Dr. Gombar joined the Drug Metabolism Department at Smith, Kline & French Laboratories. He studied the metabolism and pharmacokinetics of various drug candidates in animals and humans. He also maintained a basic research program applying pharmacokinetic principles to the risk evaluation of chemical carcinogens through an adjunct appointment at Temple University. During this time he served on the editorial boards for the journals Cancer Research and Drug Metabolism and Disposition. Dr. Gombar embarked on his career in Project Management in 1989. From 1989 to 1993 he was project leader for several cardiovascular development projects at SmithKline Beecham, including carvedilol (Coregâ, Kredexâ) which was successfully registered worldwide for the treatment of hypertension and congestive heart failure. In 1993 Dr. Gombar joined Sterling Winthrop (which became Sanofi Winthrop) as Senior Project Director. While there, his project responsibilities included the antiplatelet agent clopidogrel (Plavixâ) as well as various antitumor agents, NSAIDs and line extensions for the anti-rheumatic Plaquenilâ. He then spent time managing the Clinical Monitoring and Project Management Departments at Bio-Pharm Clinical Services, a CRO, and as a Project Director at Knoll Pharmaceutical Co. where he was responsible for the development of Ancrod for stroke as well as teams developing agents for schizophrenia and Parkinson’s disease. Dr. Gombar joined Wyeth Research in 1997 where he is currently Vice President, R&D Strategy and Business Improvement. In this role, Dr. Gombar will help prepare Wyeth’s R&D for success in the new emerging regulatory and commercial environment. Prior to his current assignment, Dr. Gombar lead the team developing methylnaltrexone for treatment of opioid-induced constipation and post-operative ileus. The methylnaltrexone team was Wyeth Research’s first “High-Impact” development team. Before the Methylnaltrexone assignment Dr. Gombar was Vice President, Project Management, responsible for all R&D projects in Neuroscience and Women’s Health & Bone, as well as drug development training for all project team members. While at Wyeth he has served as project leader for the development of zaleplon (Sonata), new indications for the antidepressant venlafaxine (Effexor XRâ), and other agents being developed for Alzheimer’s disease, schizophrenia, neuropathic pain, and stroke. In 2005 Dr. Gombar co-lead the Wyeth Research portion of the corporate-wide “Springboard” project. The goal of Springboard was to prepare Wyeth for the future, and the goal of the R&D portion of Springboard was to design the “Clinical Development Paradigm of the Future”. The key outcome of the R&D Springboard project was the implementation of the “Learn & Confirm” paradigm for pharmaceutical product development. Dr. Gombar has been active in various Project Management organizations such as the Project Management subsection in PMA (now PhRma) and was the first chairperson of the Project Management Special Interest Advisory Group in DIA. He has been involved in developing and teaching courses for PERI since 1997. He is also serving on the curriculum committee and teaching faculty for the American Course on Drug Development and Regulatory Science being sponsored by the University of California, San Francisco.
